DEVICE: CapSure Sense MRI™ SureScan™ (00643169448858)
Device Identifier (DI) Information
CapSure Sense MRI™ SureScan™
407452
In Commercial Distribution
MEDTRONIC, INC.
407452
In Commercial Distribution
MEDTRONIC, INC.
LEAD 407452 MRI US BI MVC RCMRCD
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
Yes | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35223 | Endocardial/interventricular septal pacing lead |
An implantable wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may transmit intrinsic electrical activity from the heart back to the pulse generator. The electrode end is normally placed through a vein to contact the endocardium where it is fixed, or to penetrate the myocardium of the interventricular septum adjacent to the HIS-Purkinje system; the other end is connected to the pulse generator. It may be impregnated with a steroid intended to reduce inflammation.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DTB | permanent pacemaker Electrode |
NVY | Permanent defibrillator electrodes |
NVN | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P830061 | 127 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: exactly 77 Degrees Fahrenheit |
Handling Environment Temperature: between 59 and 86 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 52.0 Centimeter |
Device Record Status
c7fb4e8a-0778-4223-8eea-c2af2e87f654
March 20, 2024
5
February 05, 2017
March 20, 2024
5
February 05, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com